Hard disk drive medical monitor with sound-proofing

ABSTRACT

A medical monitor is disclosed for implantation in a human body for monitoring biological activity and states as detected by implanted sensors. The medical monitor includes at least one hard disk drive. A transmitter and receiver for produces and transmits signals. The medical monitor is in communication with the sensors, by which information on biological activity and states is stored on the at least one disk drive. An enclosure surrounds the at least one hard disk drive, where the enclosure includes sound-proofing materials.

The present application is related to patent applications entitledRechargeable Hard Disk Drive Medical Monitor, Hard Disk Drive MedicalMonitor With Security Encryption, Hard Disk Drive Medical Monitor WithMirrored HDDs, Hard Disk Drive Medical Monitor With GPS, Hard Disk DriveMedical Monitor With Shock-Proofing, Hard Disk Drive Medical MonitorWith Electrical Grounding System, and Hard Disk Drive Medical MonitorWith Alert Signaling System, Ser. No. ______ bearing attorney docketnumbers HSJ9-2004-0011US1 (60717-343501), Ser. No. ______HSJ9-2004-0011US2 (60717-343502), Ser. No. ______ HSJ9-2004-0011US3(60717-343503), Ser. No. ______ HSJ9-2004-0011US5 (60717-343505), Ser.No. ______ HSJ9-2004-0011US6 (60717-343506), Ser. No. ______HSJ9-2004-0011US7 (60717-343507), Ser. No. ______ HSJ9-2004-0011US8(60717-343508) respectively, which are commonly assigned and filedco-temporaneously.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and devices formonitoring of biological activity, and more particularly to a medicalhard disk drive monitor to be implanted in a patient for gathering andmonitoring of the patient's medical information.

2. Description of the Prior Art

Advances in medical science are now making possible treatments for manydiseases and disabilities which would have been impossible before.Accurate diagnosis is crucial for treatment in most medical situations,and accumulation of data is nearly always a pre-requisite to accuratediagnosis. Certain medical conditions require accumulation of data overa long period of time in order to identify patterns in symptoms ortrends in biological parameters which may be monitored, such as heartrate, blood pressure, enzyme levels in the blood stream, etc. Thisaccumulated data over the course of many days, weeks, or even years mustbe collected and organized for analysis. With the continuingminiaturization of data storage devices, such as hard disk drives(HDDs), it has become possible to implant data storage devices into apatient's body, so that data from implanted sensors can be more easilycollected. The ever-expanding capacity of these data storage devicesmeans that data can be gathered for longer and longer periods withoutremoval or replacement of the HDD.

Prior medical HDD monitors have been found to have certain limitationsand to lack certain desirable features. In particular, it would bedesirable that since the device is implanted in the user's body that itbe provided with a power source which is easily recharged withoutsubjecting the user to unnecessary surgery. It is also desirable thatthe data collected and transmitted by the medical HDD monitor would beencrypted, to ensure the user's privacy. Another desirable feature isthat the HDD monitor would have an included mirrored HDD to make surethat the data, which may literally be a matter of life and death to theuser, is held in a back-up copy. An additional desirable feature is thatthe medical HDD monitor would be sound-proofed, to provide the user withprivacy, and to avoid occasional embarrassment. It is also desirablethat the medical HDD would be provided with a system for tracking theuser's whereabouts, in case of a medical emergency. Another desirablefeature would be that the medical HDD be prevented from shocks andconcussions by a shock protection system. A further desirable featurewould be for the medical HDD monitor to be provided with an electricalgrounding system to protect the medical HDD monitor, so that in case ofexposure to high voltage or current spikes, perhaps while the user isbeing resuscitated by a defibrillation device, the medical HDD is notdamaged. Also, it would be desirable that the medical HDD monitor beequipped with a signaling device that could alert either the user ormedical personnel in case of a detected medical emergency or condition.

Thus there is a need for a medical HDD monitor which would be protectedfrom intrusion by encryption of information, would also be available ina redundant mode, would have transmission signals in the radio frequencyrange, would be fabricated with sound-proofing materials, would beequipped to communicate with satellite communication signals via thepublic GPS frequencies and protocol, would also be available withmaterials and electronics that adequately ground the drive from exposureto high voltage or current spikes, would be easily rechargeable withminimal disturbance to the user, and which is also protected frommechanical shocks and concussions.

SUMMARY OF THE INVENTION

A medical HDD monitor, comprised of one or more hard disk drives fordata redundancy, is used for data information gathering and data storagefrom one or more transducers which are implanted in the physical body ofthe user who is being monitored. The hard disk drive medical monitor ishoused in a series of units for shock-proofing and sound-proofing. Datacommunication between the hard disk drive and the user or medicalpersonnel is accomplished by RF signals which are encrypted for securityreasons. Additional electronics are available for communication with asatellite which can transmit emergency signals to medical personnel thatwill relay information for ambulance pickup or other medical purposes. Asignaling system provides an alert to the user or to medical personnelin case of an emergency or if certain medical states or conditions aredetected.

The medical HDD monitor is protected against corrosion and oxidationbehavior of the body plasma and other chemicals or by-products of thehuman body. An inert material surrounding the device protects the harddrive and its components from the corrosive and oxidative nature of thehuman body. An electrical grounding system is provided which can protectthe medical HDD monitor from high voltage and current spikes. Arecharging system allows rechargeable batteries to be charged withoutremoving the medical HDD monitor or its batteries from the user's body.

Accordingly, it is an aspect of the present invention to present amedical HDD monitor that is protected from intrusion by encryption ofinformation. All data stored in the hard drive is encrypted and accessis only available to users with a proper ID and password. This ensuressafeguarding any medical information from intruders.

Another aspect of the invention is to present a medical HDD monitorwhich is available in a redundant mode so there are optionally 2 harddrives, one for storage of the data and the other for a mirror backup.The data is constantly backed up whenever new data enters the drive. Inthe event one drive should be damaged or quit working, the second orbackup drive is available for gathering information and transmittingthis information to the owner.

And another aspect of the invention is to present a medical HDD monitorwhich produces transmission signals in the radio frequency range. Thesecan either be public or private. Each transmission signal iscustomizable for specific applications.

A further aspect of the present invention is to present a medical HDDmonitor which is fabricated with sound-proofing materials which allowsultra-quiet running and performance. The noise threshold of the drive isselectable by the user so shock proofing materials can be manufacturedon the top, bottom and sides of the hard drive.

An additional aspect of the present invention is to present a medicalHDD monitor which is equipped to communicate with satellitecommunication signals via the public GPS frequencies and protocol. Thehard drive is also equipped with an electronic emergency signal so thatwhen a medical emergency should arise, i.e. heart attack, heartfibrillation, high blood sugar, etc. a signal goes out on the GPSfrequencies to advance warning selectable Doctors or Emergency crews whocould relay the information to an ambulance.

Yet another aspect of the present invention is to present a medical HDDmonitor which includes materials which help in preventing the drive fromexposures to high shock and vibration situations. If the user were to bein a high g-force environment, i.e. flying an experimental plane, thematerials surrounding the drive would protect it from the high g-forcesand prevent a head crash or hard errors.

A yet further aspect of the present invention is to present a medicalHDD monitor which is available with materials and electronics thatadequately ground the drive from exposure to high voltage or currentspikes. If the user were to be resuscitated by a defibrillation device,the hard drive is protected from the high voltage and current spikesapplied to the chest cavity. These voltage and current spikes are nottransmitted to the hard drive but are either buffered or grounded fromentering the environment of the hard drive.

An additional aspect of the present invention is to present a medicalHDD monitor which is protected against corrosion and oxidation behaviorof the body plasma and other chemicals or by-products of the human body.Exposure to fluids in the human body would lead to corrosion andoxidation of electronic components which would lead to failure of thehard drive. An inert material surrounding the drive has the ability toprotect the hard drive and its electronics from the corrosive andoxidative nature of the human body.

Briefly, one embodiment of the present invention is a medical monitorfor implantation in a human body for monitoring biological activity andstates as detected by implanted sensors. The medical monitor includes anenclosure surrounding at least one hard disk drive, and also includes atransmitter and a receiver for producing and transmitting signals in theradio frequency range. The medical monitor is in communication with thesensors, by which information on biological activity and states isstored on the one or more hard disk drives. It also includes arecharging system including at least one rechargeable battery and aninduction electronics interface. The battery state is loggedcontinuously on the hard disk drive. If the voltage level changes withtime are not within the specifications given by the manufacturer then analgorithm that computes the slope of the discharge or current drain ratewith time can predict how long the battery pack can survive withoutrecharging.

An advantage of the present invention is that batteries can be rechargedwithout removing the batteries or the medical monitor from the user'sbody.

Another advantage of the present invention is that it includes an alertmechanism, which can be of many different types to alert the user ormedical personnel of medical conditions or of necessary batteryrecharge.

And another advantage of the present invention is that the medicalmonitor system includes a grounding device which can protect the medicalmonitor from high voltage or current spikes, in case defibrillationequipment is used to revive the user.

A further advantage of the present invention is that the medical monitorcan be programmed and communicated with through radio frequencycommunications by an external programming device, and that thesecommunications are preferably encrypted to ensure privacy.

A yet further advantage is that the medical monitor is protected byshock-proofing material which preferably includes one or more miniatureair bags to prevent damage to the disk drive or drives.

These and other features and advantages of the present invention will nodoubt become apparent to those skilled in the art upon reading thefollowing detailed description which makes reference to the severalfigures of the drawing.

IN THE DRAWINGS

The following drawings are not made to scale as an actual device, andare provided for illustration of the invention described herein.

FIG. 1A is a schematic diagram of the medical HDD monitor of the presentinvention and associated components located in and around a user's body;

FIG. 1B is a detail view of the medical HDD monitor of the presentinvention

FIG. 2 shows a block diagram of a first embodiment of the medical HDDmonitor of the present invention, which uses a twin HDD system;

FIG. 3 shows a block diagram of a second embodiment of the medical HDDmonitor of the present invention, which uses a single HDD system;

FIG. 4 shows a block diagram of the internal components of the medicalHDD monitor of the present invention;

FIG. 5 shows a flow chart showing a software implementation used in themedical HDD monitor of the present invention, which uses a twin HDDsystem; and

FIG. 6 shows a flow chart showing the setup and programming of themedical HDD monitor by the external programming device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

An embodiment of the present invention is a medical hard disk drivedevice and system. As illustrated in the various drawings herein, andparticularly in the view of FIG. 1, a form of this preferred embodimentof the system of the inventive device is depicted by the generalreference character 10 and for ease of reference, the medical hard diskmonitor device will be referred to as medical HDD monitor 11.

Generally, the presently preferred embodiment of medical HDD monitor 11includes one or more hard disk drives that are encapsulated into asquare box approximately one inch thick with a length and width aroundthree inches square. It is placed surgically in the lower abdomen, justunderneath the skin (subdirmic implantation), on the right or left sideof the body. It can also be surgically implanted into the chest cavityfor proximity to the heart and lungs in a data monitoring arrangementfor closely following these vital organs. The medical HDD monitor 11 isimplanted under the skin via local or general anesthesia. The medicalHDD monitor 11 is battery operated and longevity of the batterypreferably ranges at least five years. When the battery level is low,even after attempts at recharging, an alarm will sound indicating itneeds to be replaced surgically. The alarm system will also indicatewhen the body transducers indicate either an abnormally high or lowlevel. The medical HDD monitor 11 will also contact the doctor or nurseteam when these alarms occur. The programmer in the doctor's office, orat the hospital, will tell via computer what the alarm is for and how toprocess the fault indication.

FIG. 1A shows a patient 1 which has been fitted with a number of monitorsensors 2. These sensors 2 are one or more transducers which collectdata on the state of various bodily functions of the patient such asheart rate, blood pressure, blood sugar levels, etc. and report them tothe medical HDD monitor 11, also shown in a detail view in FIG. 1B. Themedical HDD monitor 11 has preferably been surgically implanted in thepatient's body, preferably in the abdomen or chest area. The sensors 2communicate with the medical HDD monitor 11 by radio frequencytransmissions, or by micro-cables 3 which connect to the medical HDDmonitor 11, where data is stored for later retrieval and analysis. Themedical HDD monitor 11 may be set to take samples from the sensors 2 atregularly scheduled intervals, or the data collection may be triggeredby some events, such as a detected irregularity of heartbeat, change inblood pressure, etc.

The user 1, programmer, doctor, nurse or medical team preferably uses anexternal programming device 4, to program the initialization and thenthe final setup of the medical HDD monitor 11. The external programmingdevice 4 is preferably a small computer, handheld (PDA) 5 or laptopmodel 6, which allows data transfer to and from the medical HDD monitor11 via a wire-less transceiver personal network.

FIG. 1B shows a detail view of the medical HDD monitor 11, whichincludes at least one hard disk drive (HDD) 12, as well as a radiofrequency receiver 13 and transmitter 15. As discussed below, themedical HDD monitor 11 transmitter and receiver include a GPS receiver46 and GPS transmitter 41 to communicate with satellite communicationsignals via the public GPS frequencies and protocol. The medical HDDmonitor 11 is also preferably equipped with encryption software 44 whichis set up with a user ID and password system 19, and a log of intrusions17, or attempted intrusions, which can be accessed by the user 1 or byauthorized medical personal through the external programming device 4,as necessary.

FIG. 2 shows a detail view of one preferred embodiment of the medicalHDD monitor 11. The medical HDD monitor 11 includes 2 hard disk drives12 which are mounted near each other for digital data redundancy.Preferably, there is a primary hard disk drive 14 for gathering thebiological information from the sensors (see FIG. 1) in the patient'sbody and a secondary hard disk drive, 16 which provides digitalredundancy and data backup for the primary hard disk drive 14. An I/Oconnection, 18, is used to provide communication between the primary andsecondary drives 14, 16. Typically, the secondary hard disk drive 16would be supported as a “mirror” or “stripping” or combination of both“mirroring” and “stripping” drive to the primary hard disk drive 14providing redundant backup data storage. There are 3 techniques toimplement the disk drive data redundancy and data storage backup viaRAID 0, RAID 1 and RAID 0+1 configuration. Only one configuration out ofthe 3 described can be used for the medical monitor's disk drives. Theuser or medical team can decide which is the best configuration to beused based on the best backup performance and fault tolerance acceptableand desired. This is usually decided on a case-by-case basis before themedical monitor is implanted into the patient.

RAID 0 is called data stripping and optimizes two identical hard diskdrives to read and write data in parallel, interleaved stacks. Two harddisk drives perform the same work as a single disk drive but at asustained data transfer rate, double that of a single disk alone, thusimproving data access and storage. RAID 1 is called data mirroring thatallows the device to copy and maintain an identical image of data fromone drie to a second drive. If one drive fails, the disk arraymanagement software directs all applications to the surviving drive asit contains a complete copy of the data in the other drive. This RAIDconfiguration provides data protection and increases fault tolerance tothe entire system. RAID 0+1 is data stripping and data mirroringcombined without parity (redundancy data) having to be calculated andwritten. The advantage of RAID 0+1 is fast data access (like RAID 0),but with the ability to lose one drive and have a complete duplicatesurviving drive or set of drives (like RAID 1). The backup configurationsoftware 20 to provide disk mirroring is written into the operatingsystem of both drives. A battery pack 36 is used to provide power forthe hard disk drives 14, 16.

It is of course desirable that the overall package, and thus theincluded disk drives 14, 16 be as small as possible, to be minimallyintrusive to the patient. Presently, Hitachi Microdrives are favored foruse, as they can each hold 4 GB of data, and are each roughly 1¾→×1½″,although it is to be understood that any very small size hard disk drivecan be used, and the invention is not intended to be limited to anyparticular make or model of disk drive or storage device. They are alsonot limited by small size since larger 2.5″ drives can also be used forthis purpose.

The inner enclosure 22 of the medical HDD monitor 11 is fabricated witha sealant 24 of inert materials that make it impervious to the leakageof body fluids. Materials used for this sealant could include inertepoxy sealants.

Besides sealants, additional materials are used to prevent the drivefrom exposures to high shock and vibration situations. For high g-forceenvironments, materials are chosen that surround the cavity of the harddisk drive package to protect the system from high shock and preventhard disk drive catastrophic crash or the generation of hard errors. Ashock-proofing system 26 is used which includes one or more miniaturepolyethylene air bags 28 which surrounds the inner enclosure 22 of themedical HDD monitor 11. Preferably the shock-proofing system 26 includesan upper bag 30 and a lower bag 32.

The medical HDD monitor 11 is also preferably fabricated withsound-proofing materials, 34 which will allow ultra-quiet and ultra-lowvibration during running. There are several materials which arepresently preferred for sound-proofing. These include acoustic film orfoam made of polyurethane. These can be also modified with barriers madeof vinyl. Melamine Sheet Foam which is a product made from melamineresins is also a possible material, and has the advantages that it isfire, temperature and chemical resistant and halide free. Film facedacoustic film made of PVC sprayed onto glass cloths, neoprene coatedglass cloth, and polyurethane coated glass cloth can also be used. Thesecoated cloths are then laminated with any of the following products:polyurethane film, perforated or full formed PVC, reinforced Aluminumfoil, metalized polyester film and black viscose tissue.

A battery pack 36 is used to provide power for the hard disk drives 14,16. The power is supplied to the disk drive 14 via a series of wires 38.Induction electronics and interface 40 are provided to allow re-chargingof the battery pack 36 from external electrical induction equipment,which will be discussed in more depth below.

An outer enclosure 39 is also of material which is highly resistant tocorrosion and may include sealant 24 such as that discussed above inrelation to the inner enclosure 22. The outer enclosure 39 is preferablya square box approximately one inch thick with a length and width aroundthree inches square.

The medical HDD monitor 11 is preferably protected from data intrusionvia encryption of all data storage information. All digital data storedin the hard drive is encrypted by public domain type software encryption44. The information is available only to the user and/or Doctor/Medicalstaff support team with a proper ID and password. Any intrusion bynon-users would be safeguarded by encryption of all medical information,and a log of unlawful intrusive data entries would be kept by themedical HDD monitor 11 in a stored file.

The medical HDD monitor 11 communicates in the radio frequency rangewhich is endorsed by the FCC. The transmission signals can becustomizable for a broad range of frequencies depending on the type oftransmission and receiving equipment available. The transmissionfrequencies are to be either public or private. Some medical HDD monitor11 can be selectable in the types of broadband communication commonlyused, i.e. “blue-tooth” technology, GSM band technology, etc.

The medical HDD monitor 11 is also preferably equipped with GPStechnology module including a GPS receiver 46 and RF transmitter 41 tocommunicate with satellite communication signals via the public GPSfrequencies and protocol. The RF transmitter covers transmission to alocal cell phone network, Global Star Satellite, WiFi network,government licensed or unregulated telemetry receiver.

The basic principle inherent in GPS is to determine with the bestpossible accuracy a point in space, as defined by 3 coordinates, heregeographical latitude and longitude as well as elevation above sealevel. This is done by means of triangulation and involves thedetermining of distances to at least 3 GPS satellites from the user'sGPS receiver which is embedded in the medical HDD monitor 11. Thepositions of the 3 satellites in space are known at all times by variousobservations methods and orbital computational methods. When onedistance is known, the user must be located on the surface of a spherewith the satellite at the center with a radius equal to this distance.With 2 distances known, 2 points are possible of which one will be farout in space and can be eliminated. Thus, the point in space can bedetermined by calculation.

The distance of the satellite is determined by measuring the arrivaltime of the signal from the GPS satellite. This signal carries timinginformation from the atomic clock on-board the satellite and the measuretime delay indicates the distance (multiply the time delay by the speedof light which gives the distance). The GPS receiver has a internalclock but the precision of this clock is much less than that of theatomic clocks in the satellites. The receiver clock will be somefractions of a second off but the time can still be measured. Theprecise time measurement makes use of the fact that the time offset ofthe clock in the GPS receiver 46 in the medical HDD monitor 11 isconsidered as the fourth unknown (the first 3 are the space coordinatesof the receiver). In the first approximation, the offset is consideredto be zero. If a fourth satellite signal is received and a fourthdistance is measured it will also be possible to determine with highprecision this time offset and then to find the correct spacecoordinates.

The 4 distances to the 4 satellites will only fit and determine oneparticular point in space, if the time offset has a certain value. Thiscalculation is done automatically by the software in the GPS receiver 46embedded in the medical HDD monitor 11. Thus, at least 4 satellites areneeded for a satisfactory measurement. There are at least 24 operationalGPS satellites at all times operated by the U.S. Air Force, each with anorbital period of 12 hours. The location of all the satellites isincluded in the satellite transmissions and this is stored in the harddrive of the GPS monitor. By calculating how far a satellite is via asoftware algorithm, the GPS receiver 46 in the medical HDD monitor 11can know where it is located somewhere on the surface of an imaginarysphere centered at the satellite. It then determines the sizes ofseveral spheres, one for each satellite. The medical HDD monitor 11 islocated where these spheres intersect, and thus the location of theuser, with the medical HDD monitor 11, can be tracked at all times.

The digital signals from the GPS satellites preferably are emitted at 2frequencies: 1228 and 1575 Mhz. They are received by the GPS receiver 46in the medical HDD monitor 11 and contain much detailed information. Inaddition to the timing signal, there are also data for theidentification of the satellite (its number), about the status of thesatellite clock, the satellite orbit, the current status of thesatellite (health) and various correction data. The data is divided intoframe of 1500 bits; one frame is transmitted in about 30 seconds. Thesedata are stored in the medical HDD monitor 11 and updated regularly. Theapproximate directions and distances to individual GPS satellites thatare momentarily above the horizon are calculated from the orbital data.In practice, due to the uncertainties in all the GPS measurements, i.e.errors due to reflections off surrounding elements, trees, houses, etc.the resolution of the GPS embedded instrument in the medical HDD monitor11 is good to about +/−15 meters.

Now also referring to FIG. 1, the medical HDD monitor 11 is to bemanufactured with materials and electronics that adequately ground thesystem from exposure to high voltage and current spikes. If a user wereto be resuscitated by a defibrillation device, the medical HDD monitor11 would be protected from the high current spikes applied to the chestcavity. These voltage and current spikes would not be transmitted to themedical HDD monitor 11. The materials used surrounding the medical HDDmonitor 11 would transmit or ground the voltage or current spikes anddirect them away from the electronics to a grounding structure 50.

The grounding structure 50 of the medical HDD monitor 11 preferably is agrounding receptacle 52 that includes an implanted receptacle 54 andoptionally a mating non-implanted receptacle 56 (see FIG. 1). Theimplanted grounding receptacle 54 is preferably a metalized plate 58which is made of conductive metal, i.e. stainless steel, or aluminum andwhich directs the high voltage spikes or current spikes away from themedical HDD monitor 11. The charge from this plate 58 is slowlydissipated throughout the human body since the grounding plate 58 isalready immersed in a conductive bodily fluid. A charge on the groundingplate 58 will be conducted away by the electrical action of the body'smuscle and fiber cells.

One type of non-implanted grounding receptacle 56 may be an externalplate 60 to be carried by the user adjacent to the internal plate 58. Ifthe high voltage spike is large enough potential, it will direct thevoltage from the implanted metalized plate 58 across the skin interfaceand directly onto the external plate 60 that is carried by the user,i.e. on a belt, etc.

The non-implanted grounding receptacle 56 carried on the user's belt canalso be wired to an external grounding wire 62 that is carried by one orboth shoes 64. This allows a high voltage spike to be transferred fromthe inside of the body, to the non-implanted grounding receptacle 56 onthe belt, to the shoes 64 and then to the earth via the shoes 64.

FIG. 3 shows an alternate embodiment 100, in which a single disk drive12, which is the primary disk drive 14, is included in the innerenclosure 22. The secondary disk drive 16 is then located external tothe patient's body, perhaps on a belt, or on the patient's nightstand.The primary and secondary disk drives 14, 16 are in radio frequencycommunication with each other, and the secondary disk drive 16 may bebacked up periodically, perhaps once a day, or on some other schedule.As before, a grounding structure 50 and signal alert 42 are included.The alert 42 mechanism may be used to remind the patient of the back-upscheduled time.

Referring now also to FIG. 2, the medical HDD monitor 11 is equippedwith an electronic emergency signal 48 so that when a medical emergencyarises, i.e. heart attack, heart fibrillation, high blood sugar, etc., asignal would go out on the GPS frequencies to advance warningpre-selectable doctors or emergency personnel. These personnel are torelay information to an ambulance. As discussed above, the medical HDDmonitor 11 is also equipped with a vibrator and/or buzzer/ringercombination signal alert 42 that will alert the user of dangerously lowor high levels of transducer activity, as well as alerting the user ofdangerously low level conditions of DC power pack supply.

The emergency signal alert 42 can be implemented in several ways, andthe following are meant to show possible variations, but the inventionis not meant to be limited to them, and it will be obvious to oneskilled in the art that many other variations are possible. As will bediscussed below, the alert 42 could be a “local” alert 35, which isimplanted in the electronics of the medical monitor 10, or could be a“remote” alert 37, located elsewhere in the user's body, or evenexternal to the user's body.

Referring again now to FIG. 1 as well as to FIGS. 2 and 3, one variationincludes a subminiature piezo micro-speaker 43 which is implanted in theelectronics of the medical HDD monitor 11 or elsewhere in the body, andwhich issues a tonal frequency based on moderate frequency (0.5 to 3kHz) beep signals from inside the human body whenever an emergency inthe medical monitor system is detected. The emergency signal alert 42 isdistinguished by specific number of tonal beeps (short or long),frequency and tonal pitch (amplitude). The user can classify theemergency at hand with the number of beeps and the beep frequencyemitted by the piezo micro-speaker 43.

The piezo micro-speaker 43 can also transmit an emergency voice messagedue to a “text to speech” algorithm 68 built into firmware or software(on the HDD). The text to speech algorithm 68 then can transmit theemergency voice message via the micro-speaker 43 to issue a verbalwarning or emergency message (translated into different languagesdepending on the country of origin) that can be easily heard by theuser. The GPS communication network feature of the medical monitor isused to find out which country the patient is in. If it is Spain, forexample, the messages that would be received or transmitted aretranslated into Spanish before they are broadcast in Spanish as well asthe home language of the user. This feature is extremely useful outsidethe USA. The user can then hear the message clearly and act accordingly.The message then can be repeated increasing in audible intensity sothere's no mistake that the user will not be able to hear it at somelevel of audible intensity. This is most useful when the user is asleepor in a loud environment.

Another variation is that a small vibrational motor 45 is implanted inthe medical monitor electronics or elsewhere in the body. Thisvibrational motor 45 displays a number of vibrational beats based on theemergency being detected. The vibrational motor 45 is audibly silent butthe user can easily detect the small vibrations that emanate from thesource. The user will notice a very small vibrational buzzing or beatingcoming from the location of the medical monitor in the human body. Basedon the number of vibrational pulses or beats the user can easilydistinguish the specific nature of the emergency and act accordingly.

Yet another variation is that the medical HDD monitor 11 can alsotransmit an emergency signal through the body to a receiving device 47that can be carried on the user's belt, i.e. a pager or can be located ashort distance away, i.e. on a table in the hospital room. The opticaldisplay (LCD or LED) of the pager or receiving device 47 would show thespecific nature of the emergency of the medical monitor's system. Thepager or receiver 47 would also show the user the specific emergencyphone number(s) to call for assistance with a medical technician thatwill problem-solve the situation.

Alternately, the medical HDD monitor 11 can transmit an emergency signalthrough the airwaves at long distances. This RF signal can be picked upby the user's doctor or medical personnel team who are equipped withspecial long-distance receivers 49 that can decipher the medicalemergency and respond with the proper advice or assistance, i.e. call anambulance.

As another alternative, the medical HDD monitor 11 can also transmit anemergency signal via the GPS electronics 46 to a satellite receiverwhich would then transmit an emergency call signal to the user's medicalpersonnel team or hospital. This is most helpful when the user islocated some distance from the special receiver of the user's medicalteam, such as when in another state or country.

Typical emergency signals can be transmitted based on the followingmedical or monitor problems:

-   -   1. Low battery voltage of the medical monitor.

2. Battery can't hold a charge or can be recharged externally.

3. Medical monitor's hard drive is experiencing electrical or mechanicalproblems.

4. “SMART” technology of the hard drive is communicating hard driveproblems.

5. Non-volatile or volatile memory of the medical monitor is defectiveor not storing data correctly.

6. Body transducers high or low states are crossing a specific thresholdof detection, i.e. heart monitor shows the heart is beating too fast ortoo slow.

7. Body transducers are malfunctioning.

8. Human body's internal baclofen intrathecal pump supply is too low andneeds to be refilled with new baclofen.

9. Insulin levels are too high or too low in the bloodstream andhypoglycemia or hyperglycemia is starting to occur.

10. Blood pressure is too high or too low.

11. Blood pulse is too high or too low.

12. Pacemaker is showing signs that it needs to be repaired or replaced

13. Transplantable organ(s) is showing signs of being rejected by thebody.

14. Blood clot is forming in the lungs or heart.

15. Heart is beating in an irregular fashion.

16. Anaphylactic shock is commencing.

17. Asthmatic blockage and difficulty in breathing is starting.

18. Internal defibrillator is malfunctioning.

19. Internal pacemaker is malfunctioning.

20. Sleep apnea is starting to occur with difficulty in breathing ortotal failure to breath.

21. Electromechanical problems with artificial heart.

These are just a few examples of the many emergency situations that themedical HDD monitor 11 can detect, decipher and then transmit emergencysignal alerts 42 for quick and early assistance from medical personnel.

The alert signals may be turned off by use of the external programmingdevice 4 when the user has been made aware of and dealt with theemergency state.

As referred to above, the medical HDD monitor 11 has a recharging system31 that includes a battery pack 36, which preferably includesrechargeable batteries 33. The following description and values used arefor illustration purposes only and are not to be construed aslimitations. The preferred embodiment utilizes two 4 GB Microdrives,where each drive requires 314 ma to write (approximate value for readingalso), and 18 ma in idle mode (@3.3 V). Another 10 ma is assumed for thecontroller. Thus the current required is 46 ma idle, and 342 peak duringwriting. It is also preferred that the drives 14, 16 can be turned offby the controller 70 (see FIG. 4 below) while not using them. Rechargingpreferably uses an induction method of charging. An external power coil91 preferably is used to inductively couple energy to a subcutaneousreceiver coil 92, which, in turn, recharges the batteries 33.

The subcutaneous receiver coil 92 is preferably inserted under the skinin the chest region. A comfortable “muff” (not shown) would hold theexternal power charging coil 91 in proximity to the subcutaneousreceiver coil 92 to perform the charging operation. This could beaccomplished at night while the subject is asleep.

A suitable battery 33 type is lithium ion. A single battery 33 can hold190 mah at 3V in a size approximately 20 mm diameter×3.6 mm thick. Toallow at least 24 hours between charging intervals, 8 such batteries 33could be assembled in a battery pack 36 to supply a total of 1520 mah,in a total size of 22 mm diameter×28.8 mm thick. The expected life ofthe battery system is a minimum of 5 years, recharging once daily.

An external charger 93 provides appropriate AC to the power coil 91,that also may have sensors 94 to detect the presence of the receivercoil 92 located under the subject's skin. A preferred size of the coils91, 92 suitable to this task is less than 3″ diameter, and ⅝″ thick. Thefrequency of AC operation should preferably be contained between 60 hzand 1 kHz. Most preferred, it should be at 60 Hz, which is the frequencyof house current.

Battery charge will last over 24 hours, assuming 2.5 hours total readingand writing (314 ma×2.5 h=785 mah), 24 hours of controller operation (10ma×24 hours=240 mah), 12 hours of disk idle operation (2×18 ma×12hours=432 mah). Thus, the total daily power consumption budget isexpected to be 785+240+432=1457 mah, which is under the 1520 ma thebatteries can supply. Obviously, a larger, or smaller, battery pack maybe utilized with longer or shorter operation times.

Battery life is rated at a minimum of 5 years, even with deep cycleoperation. This is compatible with the HDD 12 expected life of also 5years. Thus the replacement cycle of the batteries 33 is to coincidewith the replacement cycle of the medical HDD monitor 11 as a whole. Inaddition, a “sleep-mode” module 69 is also preferably programmed intothe software of the system. The “sleep-mode” allows the medical HDDmonitor 11 to go into a suspended electrical mode to conserve on batteryusage. The drive performance is also optimized to minimize battery useand audible noise. Most drives use power to allow the actuator to moveas fast as possible to obtain the fastest data rate. However, for theapplication of providing a data storage device for the human body andits transducers, the drive does not need to have the fastest data rateand the fastest actuator. Since this technique makes audible noise andconsumes power, the less than 20 msec actuator seek time is not acritical requirement. By designing the drive specifically for theminimizing audible noise and rationing power (for example, via a 40-80msec or larger actuator seek time), the current usage can bedramatically reduced, at least by a factor of 25%.

The induction method of charging should not affect pacemakers and otherelectromechanical devices in the body if the RF power is kept small andisolated only to the area that the battery pack 36 is contained.However, it is possible that the system may not be suitable forindividuals who have medical devices which are very sensitive toelectromagnetic interference.

As discussed above, the medical HDD monitor 11 is also preferablyprovided with a vibrator or ringer or other emergency alert mechanism 42which can alert the user via an vibrator/ringer emergency signalwhenever the power levels have decreased to a low condition.

FIG. 4 shows the major component blocks used in the medical HDD monitor11. A CPU 70 communicates with volatile memory 72, which communicateswith Flash RAM, and non-volatile memory 74. The CPU is also in 2-waycommunication with HDD Main Drive Electronics 76, HDD Mirror Electronics78, Battery Back-up Electronics 80, Transducer Electronics 82, GPSElectronics 84, Emergency Signal Electronics 86 and DC Power andCharging Electronics, 88, all of which are in communication with thevarious registers and locations within HDD Storage 90. In addition, HDDMain Drive Electronics 76, HDD Mirror Electronics 78, are incommunication with Flash RAM, and non-volatile memory 74.

FIG. 5 shows a flowchart of major signal routing decisions undertaken bythe CPU 70 within the medical HDD monitor 11. A first decision 100 iswhether to transfer accumulated data to the primary HDD. If yes 102,then data is sent to the primary HDD 14 (see FIG. 2). If no 104, then asecond decision 106 is made whether to transfer data to the secondary,mirror HDD. If yes 108, the data is sent to the secondary HDD 16 (seeFIG. 2).

Another decision is made during a check of the power supply 110. Ifthere is a fault 112, an alarm is initiated 116. If there is no fault114, there is a check of the battery backup 118. If there is a fault120, an alarm is initiated 122. If there is no fault detected 124, acheck is made for GPS data transmission 126. If yes 128 a signal is sentwhich communicates with satellites 130, which can in turn initiate analarm 122. This decision 126 can also be initiated by the CPU 70.

A decision to transmit emergency signal data 132 can also be initiatedby the CPU 70. If yes 134, emergency data is sent 136, which can includesending data by GPS transmission 126, thus communicating with satellites130 and initiating an alarm 122.

The CPU also checks if the transducer signals of the sensors 1 (seeFIG. 1) are in HI or LOW conditions 138. If yes 140, emergency signalsare set 142, transmitted as emergency signal data 132, 136, possibly byGPS transmission 126, 130 to initiate an alarm 122.

The CPU also performs periodic checks to see if the DC batteries need tobe recharged 144 according to the current drain rate specification givenby the manufacture of the battery pack or batteries. If yes 146, aroutine is started to perform the recharge 148.

Referring now to again to FIG. 1 as well as FIG. 6, as mentioned above,the user 1, programmer, doctor, nurse or medical team preferably uses anexternal programming device 4, to program the initialization and thenthe final setup of the medical HDD monitor system 10. The externalprogramming device 4 is preferably a small computer, handheld (PDA) 5 orlaptop model 6, which allows data transfer to and from the medical HDDmonitor 11 via a wire-less transceiver personal network. Thecommunication link is preferably implemented with RF (radio frequency)equipment such as 802.11a, b, or g (or all 3 protocols) or Bluetoothtechnology. The communication is also preferably hooked with 128-bitdata encryption software, AES algorithm or similar, so as to provide afail-safe and secure data transmission session free of any intrusionfrom the outside. The 2-way radio frequency link allows the reading ofall the transducer sensors 2 in the user's body 1 so the doctor ormedical team can readily determine the bio-standard condition of thehuman body upon initialization of the software and hardware.

The RF communication link uses data encryption and frequency hopping toprotect the confidentiality of vital patient information. Thecommunication will allow the medical team to quickly download and uploadcritical clinical information to and from the medical HDD monitor system11.

The 802.11 RF communication link employs a chipset that preferablysupports both 5 GHz 802.11a and 2.4 GHz 802.11b and 802.11g in itselectronics package. The chipset is smaller than the 802.11b-onlysolutions. The radio frequency (RF) transceiver itself is a single chipsupporting both 5 and 2.5 GHz frequencies. The entire 3 chip set (withMAC, baseband, and radio has less than 100 components which keeps theoverall physical footprint and financial bill of materials for the chipslower. The chipset also includes support for Wi-Fi Protected Access, AESencryption and the Cisco Compatible Extensions (CXX) which ensures thatthe client systems will work with Cisco infrastructure equipment. Thedual-band RF transceiver package is integrated with both the handheldcomputer, PDA (or laptop) as well as the Medical Monitor's electronicsembedded package.

802.11 is an open standard developed by the Institute of Electrical andElectronic Engineers (IEEE) and currently consists of four differentstandards: 802.11, 802.11a, 802.11b and 802.11g, 802.11a operates on thelicense-free 5 GHz frequency band while the others use the 2.4 GHz band.802.11b is currently the most widespread standard and can transfer datawirelessly at a speed of 5.5 Mbit/s within a range of 50 to 100 meters.

802.11a is four times faster than 802.11b, providing a speed of 27Mbit/s and a range of 20 to 100 meters. 802.11g is the latest standardand is just as fast as 802.11a but operates on the 2.4 Ghz frequencyband.

Bluetooth is a wireless specification delivering short-range radiocommunication between electronic devices that are equipped withspecialized Bluetooth chips. It lets nearly all devices talk to oneanother by creating a common language between them. All devices such ascell phones, PDAs, pagers, stereos, and other home appliances cancommunicate and connect using Bluetooth technology to form a private,personal area network (PAN).

The Bluetooth specification standard defines a short range (10-meter)radio link. The devices carrying Bluetooth-enabled chipsets can easilytransfer data at a range of 720 kbits/s with 10 meters of range throughwalls, clothing, luggage bags, and also, through the interface betweenthe skin and muscle tissue and air. The interaction between devicesoccur by itself without direct human intervention whenever they arewithin each other's range. In this process, the software technologyembedded in the Bluetooth transceiver chip triggers an automaticconnection to deliver an “accept the data flow” signal (with dataencryption methods to protect the security of information).

Each Bluetooth-enabled device contains a 1.5-inch square transceiverchip prefereably operating in the ISM (industrial, scientific, andmedical) radio frequency band of 2.40 GHz to 2.48 Ghz. This frequency isgenerally available worldwide for free without any licensingrestrictions. The ISM band is divided into 79 channels with eachcarrying a bandwidth of 1 MHz.

In each transceiver chip, software is embedded called the linkcontroller. This mechanism performs the functions of identifying otherBluetooth devices, connecting and transferring of data. Whenever devicescarrying Bluetooth technology are within each other's range, they createan automatic ad hoc PAN (personal area network) called a piconet. Inthis arrangement, one device acts as the “master” such as a laptop orPDA, while other devices function as “slaves” such as printers,scanners, or the Medical Monitor. A piconet normally carries up to 8devices. The master device decides if a particular communication serviceis needed from a slave device.

At the time when a connection is made between Bluetooth devices, anexchange of unique Bluetooth identity called global ID takes place. Adevice global ID indicates its profile along with capability functions.Upon matching of the device profiles, a connection is made and as thedevices exchange data (with data encryption), the Bluetooth transceiverchip hops back and forth among frequencies (frequency hopping).

A scattemet forms if a device from a piconet also acts as a member ofanother piconet. In this scheme, a device being master in one piconetcan simultaneously be a slave in the other one.

Due to the aspect of radio waves, the security concerning can beaddressed with 3 aspects: specific sequence of channel hopping knownonly to the sending and receiving devices, challenge-responseauthentication routine to verify the validity of the receiving unit, andthe 128-bit key encryption standard for securing transmission betweendevices.

One can create a personal area network at home or on the road withBluetooth-enabled devices such as a keyboard, mouse, scanner, PDA,laptop, cell phone, Medical Monitor, etc. This network can automaticallyhelp synchronize notes, calendar, address book and medical information.

The setup and programming is shown in the flow diagram of FIG. 6. Thesequence is started when a handheld computer or laptop 200 prepares datafor RF telemetry transmission and reception 202. This is encrypted bythe AES encryption algorithm 204 and sent through the skin interface 206of the user, where it is received by the medical HDD monitor's RFtelemetry transmission and reception module 208. This is decrypted bythe AES encryption algorithm 210, and sent to the medical monitor CPU212 where it is sent to the medical monitor's volatile RAM 214. Fromthere it may be sent to the medical HDD monitor's non-volatile RAM 216or to the medical HDD monitor's hard drive or drives 218.

While the present invention has been shown and described with regard tocertain preferred embodiments, it is to be understood that modificationsin form and detail will no doubt be developed by those skilled in theart upon reviewing this disclosure. It is therefore intended that thefollowing claims cover all such alterations and modifications thatnevertheless include the true spirit and scope of the inventive featuresof the present invention.

1. A medical monitor for implantation in the user's body for monitoringdata on biological activity and states gathered from sensors implantedin the user's body, said medical monitor comprising: at least one harddisk drive; a transmitter and receiver for producing and transmittingsignals, said medical monitor being in communication with said sensors,by which information on biological activity and states is stored on saidat least one hard disk drive; and an enclosure surrounding said at leastone hard disk drive, said enclosure including sound-proofing materials.2. The medical monitor of claim 1, wherein: said sound-proofingmaterials are chosen from a group consisting of polyurethane acousticfilm, polyurethane foam, vinyl barriers, melamine sheet foam, film facedacoustic film made of PVC sprayed onto glass cloths, neoprene coatedglass cloth, and polyurethane coated glass cloth.
 3. The medical monitorof claim 2, wherein: said cloths are laminated with a material chosenfrom the group consisting of polyurethane film, perforated PVC, fullformed PVC, reinforced aluminum foil, metalized polyester film and blackviscose tissue.
 4. The medical monitor of claim 1, wherein: seek timeand current usage parameters are designed to minimize audible noise fromsaid hard disk drive.
 5. The medical monitor of claim 1, furthercomprising: a recharging system including at least one rechargeablebattery and an induction electronics interface.
 6. The medical monitorof claim 1, wherein: transmissions are encrypted as encryptedinformation for security of the user.
 7. The medical monitor of claim 1,wherein: said at least one hard disk drive comprises a primary drive anda secondary drive, wherein said secondary drive mirrors said primarydrive.
 8. The medical monitor of claim 1, further comprising: a GPStransmitter and a receiver for producing and receiving transmissionsignals in the radio frequency range, said a GPS transmitter for sendingsatellite communication signals via the public GPS frequencies andprotocol.
 9. The medical monitor of claim 1, wherein: said enclosureincludes a shock-proofing system.
 10. The medical monitor of claim 1,further comprising: an electrical grounding structure which diverts highvoltage or current spikes from said at least one disk drive.
 11. Themedical monitor of claim 1, further comprising: an alert mechanism whichis used to signal the user of medical and maintenance conditions.
 12. Asystem for monitoring biological activity and states in the body of auser, comprising: a medical HDD monitor, including at least one harddisk drive, a transmitter and a receiver for producing and transmittingsignals in the radio frequency range and an enclosure surrounding saidat least one hard disk drive, said enclosure including sound-proofingmaterials; at least one sensor for communicating data from at least onesite in said body of said user to said medical HDD monitor; and anexternal programming interface which communicates with said medical HDDmonitor by radio frequency transmission, in order to set performanceparameters of said medical HDD monitor.
 13. The system of claim 12,wherein: seek time and current usage parameters are designed to minimizeaudible noise from said hard disk drive.
 14. The system of claim 12,wherein: said at least one sensor communicates with said medical HDDmonitor by radio frequency transmissions.
 15. The system of claim 12,wherein: said at least one sensor communicates with said medical HDDmonitor by micro-cables.
 16. The system of claim 12, wherein: saidmedical HDD monitor includes a recharging system including at least onerechargeable battery and an induction electronics interface.
 17. Thesystem claim 12, further comprising: an external programming devicewhich is in radio frequency communication with said medical HDD monitor.18. The system of claim 17, wherein: said external programming device ischosen from a group consisting of hand-held computers and laptopcomputers.
 19. The system of claim 18, wherein: said externalprogramming device communicates with said medical HDD monitor throughencrypted communications.
 20. The system of claim 12, wherein: said atleast one hard disk drive includes two disk drives, which are incommunication with each other, to provide disk drive data redundancy anddata backup; and said disk drive data redundancy and data backup isaccomplished by an operating configuration chosen from the groupconsisting of RAID 0, RAID 1, or RAID 0+1 techniques